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Guidance for Industry
Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions
Annex 1
Residue on Ignition/Sulphated Ash General Chapter
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U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
February 2008
ICH
Guidance for Industry 1.
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions
Annex 1
Residue on Ignition/Sulphated Ash General Chapter
| This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. |
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. 3.
This annex is the result of the Q4B process for Residue on Ignition/Sulphated Ash. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, Ph.Eur. 20414 Sulphated Ash, JP 2.44 Residue on Ignition Test, and USP <281> Residue on Ignition can be used as interchangeable in the ICH regions given the following:
1. (2.1.1) Unless otherwise specified in a monograph, an appropriate sample weight is chosen, typically 1-2 g, to result in a level of residue sufficient to be accurately measurable by weight (typically 1 mg). If not specified in the monograph, the appropriate sample weight should be justified, and the sample weight and the acceptance criteria should be specified in the application dossier.
2. (2.1.2) The muffle furnace should be appropriately calibrated to ensure compliance with regional GMP requirements.
The proposed texts evaluated did not contain acceptance criteria.
When this annex is implemented (incorporated into the regulatory process at ICH Step 5) in a region, it can be used in that region. Timing may differ for each region.
A. General Consideration (4.1)
When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeial texts that are referenced in section II.A (2.1) of this annex, any change notification, variation, and/or prior approval procedures should be handled in accordance with established regional regulatory mechanisms pertaining to compendial changes.
Based on the recommendation above, and in accordance with the conditions set forth in this annex, the pharmacopoeial texts referenced in section II.A (2.1) of this annex can be considered interchangeable. However, FDA might request that a company demonstrate that the chosen method is acceptable and suitable for a specific material or product, irrespective of the origin of the method.
For the European Union, the monographs of the Ph. Eur. have mandatory applicability. Regulatory authorities can accept the reference in a marketing authorization application, renewal or variation application citing the use of the corresponding text from another pharmacopoeia as referenced in section II.A (2.1), in accordance with the conditions set out in this annex, as fulfilling the requirements for compliance with the Ph. Eur. Chapter, Sulphated Ash: 20414, on the basis of the declaration of interchangeability made above.
The pharmacopoeial texts referenced in section II.A (2.1) of this annex can be used as interchangeable in accordance with the conditions set out in this annex. Details of implementation requirements will be provided in the notification by MHLW when this annex is implemented.
A. (5.1) The PDG Stage 5B sign-off document: Japanese Pharmacopoeial Forum Volume 14, Number 4 (December 2005). (Note: the PDG cover letter published in this volume was subsequently changed based on Q4B comments.)
B. (5.2) The pharmacopoeial references for Residue on Ignition/Sulphated Ash for this annex are:
1. (5.2.1) European Pharmacopoeia (Ph. Eur.): Supplement 5.6 (official on January 2007) (reference Sulphated Ash 01/2007:20414)
2. (5.2.2) Japanese Pharmacopoeia (JP): 2.44 Residue on Ignition Test as it appears in the JP Fifteenth Edition (March 31, 2006, The Ministry of Health, Labour and Welfare Ministerial Notification No. 285)
3. (5.2.3) United States Pharmacopeia (USP): <281> Residue on Ignition official in USP 29, 2nd Supplement, August 2006
1. This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, November 2007. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States.
2. Arabic numbers reflect the organizational breakdown of the document endorsed by the ICH Steering Committee at Step 4 of the ICH process, November 2007.
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Date created: February 22, 2008 |
